Hydrotherapy With Hydrogen-rich Water vs. RICE Protocol Following Acute Ankle Sprain

Ankle Injuries Clinical Trial

— HRWAAC  

Official title:

Hydrotherapy With Hydrogen-rich Water Compared With RICE Protocol Following Acute Ankle Sprain in Professional Athletes: a Randomized Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167202
• Other study ID #: 1-HRW/2019
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2020
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The traditional treatment of soft tissue injuries consists of the RICE protocol - rest, ice, compression, and elevation, followed for up to 72 hours after a trauma. Although designed as an immediate therapy to reduce inflammation that occurs after an acute injury, the RICE might not be the best way to promote healing due to limiting blood flow. Molecular hydrogen (H2) has recently been put forward as a possible adjuvant treatment in musculoskeletal medicine, yet limited data are available concerning its effectiveness as a first-aid intervention.

Description:

Experimental protocol

• Randomized controlled parallel-group trial

• Acute (24 h) post-injury intervention:

• Hydrogen-rich water hydrotherapy

• RICE protocol

• First sessions given immediately after an initial examination (~ 60 min after the injury).

• Source of hydrogen-rich water = HRW Natural Health Products Inc. (New Westminster, BC, Canada)

o Formulation (7g/ tablets, 800mg Magnesium) dissolved into a 3-L stationary whirlpool with water (20°C)

• No other interventions during the period of evaluation

Outcomes assessed at baseline (pre-intervention) and at 24-h follow up:

• Figure-of-eight method of measuring ankle joint swelling

• Visual analogue score (VAS) score for pain at rest and during movement

• Weight-bearing lunge test (WBLT)

• Single leg balance test (SLBT) with eyes open and closed

• Serum inflammatory biomarkers (IL-1ß, TNF-α, CRP) • Early termination criteria: serious subjective side effects (e.g. tingling, discoloration of skin, burning, itching, rash)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Age 18 - 35 years

• Body mass index 19 - 25 kg/m2

• Free of major chronic diseases or acute disorders

• Acute ankle sprain incurred during sport-related activity

Exclusion Criteria:

• History of a previous ankle sprain during the past 6 months

• Unwillingness to return for follow-up analysis

Related Conditions & MeSH terms

• Ankle Injuries

Intervention

Procedure:
• Hydrogen-rich water
Hydrogen-rich water (one hydrotherapy every 4 hours)
• RICE
RICE protocol

Locations

Country	Name	City	State
Serbia	Applied Bioenergetics Lab at Faculty of Sport and PE	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

Cole AR, Perry DA, Raza A, Nedder AP, Pollack E, Regan WL, van den Bosch SJ, Polizzotti BD, Yang E, Davila D, Afacan O, Warfield SK, Ou Y, Sefton B, Everett AD, Neil JJ, Lidov HGW, Mayer JE, Kheir JN. Perioperatively Inhaled Hydrogen Gas Diminishes Neurologic Injury Following Experimental Circulatory Arrest in Swine. JACC Basic Transl Sci. 2019 Mar 27;4(2):176-187. doi: 10.1016/j.jacbts.2018.11.006. eCollection 2019 Apr. — View Citation

Ostojic SM, Vukomanovic B, Calleja-Gonzalez J, Hoffman JR. Effectiveness of oral and topical hydrogen for sports-related soft tissue injuries. Postgrad Med. 2014 Sep;126(5):187-95. doi: 10.3810/pgm.2014.09.2813. — View Citation

Ostojic SM. Should hydrogen therapy be included in a musculoskeletal medicine routine? F1000Res. 2016 Nov 10;5:2659. doi: 10.12688/f1000research.9758.1. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ankle mobility for maximal dorsiflexion in centimeters, higher score means worse outcome	Baseline vs. 24 h	Baseline vs. 24 hours post-intervention
Other	Change in single-leg balance in seconds, higher score means better outcome	Baseline vs. 24 h	Baseline vs. 24 hours post-intervention
Other	Change in serum levels of C-reactive protein	Baseline vs. 24 h	Baseline vs. 24 hours post-intervention
Primary	Change in ankle circumference for joint swelling	Baseline vs. 24	Baseline vs. 24 hours post-intervention
Secondary	Change in VAS score for pain (0-10), higher score means worse outcome	Baseline vs. 24 h	Baseline vs. 24 hours post-intervention